CLASS II Device recall · Reported 6 Nov 2013 · FDA Enforcement Report

The Centricity PACS Workstation is intended recalled by GE Healthcare It

GE Healthcare It is recalling The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis, distributed nationwide in the US. The recall was initiated on 11 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGE Centricity PACS Versions: 3.1.1.2, 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 4.0, 4.0.1

Quantity recalled623 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0116-2014
FDA event ID: 65471
Recalling firm: GE Healthcare It, Barrington, IL
Classification: Class II
Status: Terminated
Recall initiated: 11 Jun 2013
FDA classified: 30 Oct 2013
Reported: 6 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

11 Jun 2013	Recall initiated by company
30 Oct 2013	Classified by FDA	+141 days
6 Nov 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration, the "close" button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation. 2) Interrupted workflow could break the

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

Where it was distributed

Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV) and the countries of the UK, Taiwan, Switerzland, Sweden, Spain, Singapore, Saudi Arabia, Netherlands, Malaysia, Korea, Japan, Italy, Israel, India, Hong Kong, Germany, France, Denmark, China, Canada, Bermuda, Beligum and Australia.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine

Questions about this recall

Why was it recalled?

Which lots are affected?

GE Centricity PACS Versions: 3.1.1.2, 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 4.0, 4.0.1

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from GE Healthcare It

All 17

Reported	Class	Recall	Company	Reason	Where
14 Sep 2016Device	CLASS II	Centricity Enterprise Archive recalled by Ge Healthcare It	Ge Healthcare It	Device Malfunction	Nationwide
7 Sep 2016Device	CLASS II	Centricity Laboratory Core Lab System 4.1 The Centricity recalled	GE Healthcare It	Device Malfunction	6 states
24 Aug 2016Device	CLASS II	GE Centricity PACS Workstation recalled by GE Healthcare It	GE Healthcare It	Other	Nationwide
3 Aug 2016Device	CLASS II	Imagecast Pacs with Centricity Ris-ic versions prior recalled	Ge Healthcare It	Device Malfunction	Nationwide
31 Dec 2014Device	CLASS II	Centricity Enterprise Archive recalled by Ge Healthcare It	Ge Healthcare It	Device Malfunction	Nationwide

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